QUEBEC CITY, July 5, 2005 – Advitech Inc. (TSX-V: AVI), a Canadian biotech company, today reported positive results from its recently completed randomized, multi-center, double-blind, placebo-controlled clinical trial of XP-828L, its new oral product for treating mild-to-moderate psoriasis. The main objective of the 112-day study, involving 84 patients, was to confirm the efficacy and safety of XP-828L. The study was conducted by Robert Bissonnette, M.D., and Yves Poulin, M.D., two renowned dermatologists who have been involved in several clinical trials on psoriasis. In 2004, Advitech conducted an open study on eleven patients with mild-to-moderate psoriasis.
Results from the study confirm the efficacy of XP-828L compared with placebo, as measured by the Physician’s Global Assessment (PGA) scale, the primary endpoint of the study.
The PGA scale is used by physicians to evaluate the severity of patients’ disease. The PGA scale is composed of six categories according to the severity of the disease (0=none, 1=minimal, 2=mild, 3=moderate, 4=severe, 5=very severe). The PGA scale is one of the most commonly used endpoints in psoriasis clinical studies, and was considered the best measure in this study because it is well suited for evaluating mild-to-moderate psoriasis patients.
For the first 56-day phase, when comparing mean values of PGA at Day 1 and Day 56 for patients receiving XP-828L (5g/day) with the values of the patients in the placebo group, a statistically significant difference was achieved both by Student’s t-test (p=0.0395) and also by covariance analysis (p=0.0167). This result demonstrates the positive effect of XP-828L on psoriasis, an important scientific conclusion of the study and the achievement of its primary objective.
Moreover, analysis of PGA values demonstrates that 21.4% of patients treated with XP-828L experienced a reduction in the severity of their condition by at least one level on the PGA scale. These results further strengthen the Company’s claim that XP-828L can be successfully used as a viable option for mild-to-moderate psoriasis patients.
The objectives of the second 56-day phase, which did not include a placebo group, included the evaluation of:
- a higher dose of XP-828L (10 g/day versus 5 g/day) for 56 days;
- an extended treatment period of 56 days, for a total of 112 days, with the original daily dose of 5 g of XP-828L.
The results obtained after 56 days with the higher dose (10g/day) were not superior to those obtained with the initial 5g/day dose. During the second 56-day phase of treatment with the 5g/day dose, patients maintained the improvement achieved during the first phase, without additional improvement.
The study achieved another important objective by confirming the excellent safety profile of XP-828L. During the entire 112-day study, no related serious adverse event (SAE) was reported. Only one unrelated SAE was reported for a patient, explained by a pre-existing medical condition. There was no statistically significant difference either between the XP-828L group and the placebo group for laboratory values or for the number of adverse events (AE). The study involved longitudinal controls of hepatic, renal, metabolic and hematological parameters.
No patients on treatment dropped-out the study due to adverse events related to the product.
“I am extremely pleased with the results of this randomized study because they confirm that XP-828L, a natural product with an outstanding safety profile, reduces cutaneous psoriasis effectively,” stated Patrice E. Poubelle, M.D., Ds.C., Chairman of Advitech’s scientific advisory committee. “By combining a very safe product, easy oral administration and a proven efficacy, there is no doubt that patients and dermatologists alike will now have a very attractive option to consider,” he added.
Renaud Beauchesne, President and CEO of Advitech, declared: “We believe that XP-828L is now uniquely positioned to meet a major demand for a safe, convenient and effective treatment for patients affected by mild-to-moderate psoriasis. In North America alone, this group represents more than five million people who have to rely almost exclusively on topical or systemic treatments with very poor safety profiles. We believe that XP-828L will represent an attractive solution for patients concerned about the side effects of conventional drugs as well as those who wish to improve their quality of life with an easy-to-use product.”
Commenting on the results, Dr. Robert Bissonnette, one of the lead investigators of the study, mentioned: “I am pleased with the results of the study because a number of our patients are asking for safe products like XP-828L that they can take orally. XP-828L could provide an interesting alternative for people who wish to maintain or improve their condition and for whom product safety is a serious concern.”
“XP-828L could be an interesting option for mild-to-moderate psoriasis patients,” commented Yves Poulin, M.D., the co-lead investigator involved in the study and also the lead investigator in the first open study on XP-828L.
Psoriasis is an immune system disorder that affects between 2-3% of the global population and more than six million adults in North America alone. There is no effective long-term therapy for this chronic disease. All existing therapies have significant side effects that limit their long-term use. In a survey conducted in 2002 by the U.S. National Psoriasis Foundation, 78% of all respondents indicated that they were not using the more aggressive therapies because of their potential side effects. The market for psoriasis treatment is currently estimated by various sources at US $1 billion.
XP-828L is a patented growth factor complex used as an orally administered product for mild-to-moderate psoriasis and other immune-mediated chronic inflammatory diseases (I.M.I.D.).
Advitech is a biotechnology company specializing in the development of bioactive ingredients from dairy proteins. Its key focus areas are in the fields of immunology and inflammation. Advitech’s common shares are listed on the TSX Venture Exchange under the symbol AVI. The number of common shares outstanding is 54,799,818.
This press release contains forward-looking statements which reflect the Company's current expectations regarding future events. The forward-looking statements involve risks and uncertainties. Actual results could differ materially from those projected herein. The reader is cautioned not to rely on these forward-looking statements.
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